Kornimate/medical-research-clean huggingface dataset:
stroke volume variation- guided hemodynamic therapy versus oxygen extraction ratio-guided hemodynamic therapy

Conditions: Goal-directed Fluid Therapy

Summary: the flotrac/vigileo is a minimal invasive device assessing flow based hemodynamic parameters by pulse contour analysis based on the radial artery pressure signal. this method gained popularity as it is minimally invasive compared to esophageal doppler or pulmonary artery catheter insertion and provides continuous beat-to-beat data. the previous study with 110 patients found that that gdht guided by stroke volume variation (svv) using the flotrac/vigileo device was associated with a reduced length of hospital stay and a lower incidence of pogd in major abdominal oncological surgery. however, no difference was found in the incidence of postoperative complications between the two groups, lack of statistical power could be a limitation to demonstrate the true association. therefore, further prospective trials are needed to address this issue. the use of early and efficient therapeutic strategies able to detect and to treat potential triggers of organ failures, such as tissue hypoperfusion, is particularly important. if hypoperfusion is not adequately managed, tissue hypoxia could occur, resulting from an impairment of the adaptive mechanisms of myocardial contractile function, under the influence of inflammatory mediators, and the peripheral tissues will then increase their oxygen extraction (o2er). as such, gdht guided by o2er may be appropriate to monitor gdht strategies because it reflects the balance between oxygen delivery and consumption. therefore, the investigators performed this single-center, randomized, controlled trial to investigate whether gdht guided by svv using flotrac/vigileo monitor and gdht guided by o2er would reduce incidence of postoperative complication and shorten the length of hospital stay, compared with a standard conventional fluid therapy in low-to-moderate risk patients undergoing major laparoscopic gastrointestinal oncological surgery.


Eligibility criteria:
inclusion criteria: 1. 18\~80 years 2. asa i\~iii 3. patients undergoing elective major laparoscopic gastrointestinal oncological surgery.procedures were considered major if listed for resection cancer with tumor debulking, staging or reconstruction with a risk for significant surgical blood loss. exclusion criteria: 1. co-existing congestive heart failure; chronic lung disease; or renal or hepatic dysfunction (creatinine \>50 % or liver enzymes \>50 % of normal values), and arrhythmias. 2. less than 18 years 3. pregnant or lactating woman 4. patients undergoing emergency surgery

Keywords: stroke volume variation oxygen extraction ratio goal-directed fluid therapy laparoscopic gastrointestinal surgery
mini-chop and rituximab in patients aged over 80 years

Conditions: Diffuse Large B-Cell Lymphoma

Summary: the purpose of the study is to evaluate efficacy and safety of r-minichop for elderly patients with diffuse large b-cell lymphoma (dlbc) lymphoma aged over 80 years by measuring the overall survival.


Eligibility criteria:
inclusion criteria: * patient with histologically proven cd20+ diffuse large b-cell lymphoma (who classification). dlbcl with some small cell infiltration in bone marrow or lymph node may be included. * aged over 80 years. * ann arbor stage i bulky, ii, iii or iv * age-adjusted international prognostic index equal to 0, 1, 2 and 3. * patient non previously treated. * ecog performance status ≤ 2. * with a minimum life expectancy of 3 months. * negative hiv, hbv and hcv serologies test ≤ 4 weeks (except after vaccination). * having previously signed a written informed consent exclusion criteria: * any other histological type of lymphoma. * any history of treated or non-treated indolent lymphoma. * central nervous system or meningeal involvement by lymphoma. * contra-indication to any drug contained in the chemotherapy regimens. * any serious active disease (according to the investigator's decision). * poor renal function (creatinin level\>150µmol/l), poor hepatic function (total bilirubin level\>30mmol/l, transaminases\>2.5 maximum normal level) unless these abnormalities are related to the lymphoma. * poor bone marrow reserve as defined by neutrophils \<1.5 g/l or platelets \<100 g/l, unless related to bone marrow infiltration. * any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. * treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study. * adult patient under tutelage.

Keywords: diffuse large b-cell lymphoma
transfer of microorganisms between green areas and humans

Conditions: Microbial Colonization

Summary: the goal of this study is to understand how visiting green areas affects the human microbiome through microbial transfer. additionally, the project aims to understand which environmental, health and lifestyle factors can influence these microbiome changes. participants will visit a green area, provide microbiome samples before and after the visit, and complete questionnaires related to environmental, health, lifestyle and demographic factors.

several hypotheses propose that the modern surge in immune disorders is related to diminished contact with nature. specifically, the biodiversity hypothesis emphasizes that contact with natural environments enriches the human microbiome and is necessary for promoting immune balance. this project aims to investigate whether visiting green areas can contribute to changes in human microbiome composition. additionally, the investigators aim to explore the environmental, health and lifestyle factors that can influence these microbiome changes. adults and/or children will be asked to visit a green space (such as an urban park) and perform specific activities (such as walking or pushing a stroller) for a defined time period. before and after this visit, swabs of their skin and nose will be collected to analyze microbiome changes. in addition, questionnaires will be administered to the participants, with the goal to align microbiome changes with environmental, health, lifestyle and demographic factors.

Eligibility criteria:
inclusion criteria: children (min. 4 years old) and adult participants (18+) of any gender in generally good health. no strict exclusion criteria will be set in advance.

Keywords: green areas nature microbiome biodiversity sequencing
study of cm512 injection in subjects with moderate-to-severe asthma

Conditions: Asthma

Summary: this study is a multicenter, randomized, double-blind, placebo-controlled phase ii clinical trial evaluating the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of cm512 in subjects with moderate-to-severe asthma.


Eligibility criteria:
inclusion criteria: * able to understand and comply with procedures of the protocol, and voluntarily sign the informed consent form. * age ≥ 18 years old and ≤ 75 years old. * body mass index (bmi) ≥ 18.0 kg/(m\*m). * documented treatment with medium to high dose inhaled corticosteroids (ics) in combination with asthma controller medication for at least 3 months with a stable dose ≥1 month prior to visit 1. * documented history of at least 1 severe asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ics. * asthma control questionnaire-6 (acq-6) score ≥1.5 exclusion criteria: * women of childbearing potential have a positive pregnancy test result during the screening period; women who are pregnant or lactating. * with a history of drug abuse within the past 5 years before screening visit. * allergic or intolerant to cm512 injection or placebo components, or with a history of severe drug allergies or anaphylactic shock. * with any medical or non-medical conditions that are not suitable for participation in this study by investigators.
safety and efficacy study of alfimeprase in subjects with occluded central catheters

Conditions: Thrombosis; Venous Thrombosis

Summary: the purpose of the study is to compare the safety and effectiveness of alfimeprase to a placebo in restoring function of occluded central catheters.

primary outcomes: the ability to withdraw at least 3 ml of blood and infuse more at least 5 ml of sterile saline through the occluded catheter lumen at 15 minutes after receiving initial instillation of study drug. secondary outcomes: the ability to withdraw at least 3 ml of blood and infuse at least 5 ml of sterile saline through the occluded catheter lumen at 30 minutes following a single instillation of study drug and at 30 minutes following a second instillation of study drug if patency is not restored within 30 minutes of the first instillation. safety: * adverse events * major bleeding events * change in laboratory values.

Eligibility criteria:
inclusion criteria: * must give written informed consent * unable to withdraw 3 ml of blood from a central venous access device * hemodynamically stable * available for follow-up assessments exclusion criteria: * inability to infuse at least 2 ml of saline through the catheter * catheter placed less than 48 hours prior to detection of occlusion * catheter used for hemodialysis of pheresis * less than 18 years of age * evidence of mechanical or nonthrombotic occlusion * receipt of any thrombolytic agent within 24 hours of randomization * in the opinion of the investigator, subject is at "high risk" for bleeding events of embolic complications, or has a condition for which bleeding constitutes a significant hazard * increased risk for drug extravasation * pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator) * known right-to-left cardiac shunt, patent foramen ovale, or atrial/ventricular septal defect * participation in any other study of an investigational device, medication, biologic, or other agent within 30 days before enrollment and until the 30-day follow up visit * any other subject feature that in the opinion of the investigator should preclude study participation

Keywords: occluded central catheter central venous access devices dysfunction withdrawal occlusion thrombosis venous thrombosis
myofascial release and muscle activity

Conditions: Self Myofascial Release; Muscle Tone Abnormalities

Summary: the aim of the study is to assess the impact of smr intervention in the hamstring muscles on the activity of the biceps and gluteus muscles.

the study will cover 40 men, players of amateur football leagues, aged 18 - 40. the test will include the measurement of semg of the biceps and gluteal muscles during the exercise, followed by myofascial self-release (smr). muscle semg was re-measured immediately after roller therapy.

Eligibility criteria:
inclusion criteria: * signing informed consent to participate in the study * age in the range of 18-40 years exclusion criteria: * people who had orthopedic injuries to the lower limbs and the lumbar-pelvic-iliac complex in the last year * people who reported pain in the lower limbs and the lumbar-pelvic-iliac complex on the day of the examination * people who underwent myofascial therapy in the last 6 weeks * people with non-specific neuromuscular disorders
effect of the use of navigation in the alignment obtained when performing a total knee arthroplasty in obese patients

Conditions: Osteoarthritis, Knee; Obesity; Arthropathy of Knee

Summary: naobe is a randomized, open and prospective clinical trial that evaluates the accuracy to achieve an adequate mechanical axis of the lower extremity in obese patients after total knee replacement.

randomized, open and prospective clinical trial. following the surgical indication for a total knee replacement as treatment for symptomatic osteoarthritis and the confirmation of obesity (bmi equal or greater than 30 kg/m2 ), patients will be randomly assigned (ratio 1:1) to one of the following treatments: control group: total knee arthroplasty implanted with standard guides . experimental group: total knee arthroplasty(tka) implanted with gps navigation system patient (or their legal guardian) must provide/sign the informed consent prior to inclusion in the study. after the surgery, patients will be followed-up at 6 weeks, 3, 6 and 12 months. at those times, data regarding physical and radiological examinations, pain and functionality and health status questionnaires will be collected.

Eligibility criteria:
inclusion criteria: * men and women over 18 years old. * written informed consent according to ich / gcp and spanish legislation, obtained before any study procedure. * patient with a bmi equal to or greater than 30 kg / m2 * patients with clinical and radiological criteria of knee osteoarthritis. * patients with indication for primary tka according to medical criteria. exclusion criteria: * pregnancy or lactation. * inability to give informed consent in the absence of a legal representative. * subjects that are participating in a study with medicines or other medical devices. * those who show inability to follow the instructions or collaborate during the development of the study. * if in the opinion of the researcher there are findings in the physical examination, abnormalities in the results of the clinical analyzes or other medical, social or psychosocial factors that could have a negative influence * having had a previous surgical procedure on or around the knee in the last 12 months (such as proximal tibial osteotomy, femoral osteotomy, open reduction and internal fixation for a fracture, patellectomy or patellar realignment). * need a simultaneous bilateral tka. * have a varus angle or valgus ≥ 15 °. * total revision knee arthroplasty.

Keywords: osteoarthritis, knee obesity knee replacement arthroplasty
analysis of the resistance and sensitivity mechanisms to teclistamab by focusing on single immune cell examination

Conditions: Multiple Myeloma

Summary: the aim of this study is to discover the immune and oncogenomic features that distinguish patients who respond to teclistamab from patients who are primarily resistant. moreover, phenotypic and genotypic characteristics that occur with secondary resistance to teclistamab will be analyzed.


Eligibility criteria:
inclusion criteria: * with multiple myeloma * who receive teclistamab * consent form signed exclusion criteria: * patient under legal protection

Keywords: teclistamab resistance immune cell
volume targeted mask ventilation versus pressure ventilation in preterm infants

Conditions: Neonatal Respiratory Distress

Summary: this is a pilot trial to assess the feasibility of volume targeted ventilation in the delivery room. preterm infants will be randomized to pressure guided or volume targeted ventilation during respiratory support in the delivery room


Eligibility criteria:
inclusion criteria: * born between 23+0/7 to 28+6/7 weeks' gestation * considered suitable for full resuscitation, i.e., no parental request or antenatal decision to forego resuscitation * informed parental consent exclusion criteria: * major congenital or chromosomal malformation * conditions that might have an adverse effect on breathing or ventilation (e.g., high risk for lung hypoplasia, congenital diaphragmatic hernia) * congenital heart disease requiring intervention in the neonatal period * hydrops requiring intervention in the neonatal period * neonatal resuscitation initiated before nicu team arrival * infants who are born outside of study center and transported to center after delivery
study on brain function of obesity classification

Conditions: Obesity; Functional Neuroimaging

Summary: the purpose of this study was to investigate the differences and similarities of brain function in patients with four subtypes of obesity, and the relationship between brain function changes and complications after weight loss and metabolic improvement. 120 patients with obesity and 30 healthy individuals with normal bmi were enrolled.

although the investigators have clinically observed significant differences in appetite and metabolic status in patients with the above four types of obesity, the brain functional characteristics of different obesity subtypes and their relationship with metabolic markers are still unclear. based on this, in this project, the investigators plan to explore further the similarities and differences in brain function in patients with four subtypes of obesity and the relationship between brain function changes after weight loss and metabolic improvement and the occurrence of complications. 120 patients with obesity and 30 healthy individuals with normal bmi were enrolled. all patients with obesity underwent lsg. a multidisciplinary team evaluated participants with obesity at baseline, 1, 3, 6, and 12 months after laparoscopic sleeve gastrectomy (lsg). anthropometrics, metabolic indicators, sex hormones, menstruation，glucose-lipid metabolic markers, and hepatic steatosis assessed by fibroscan(cap value and e value) were measured baseline and postoperative. resting and task state functional magnetic resonance imaging (fmri) measurements were performed at baseline for all participants at two-time points before and after meals. measurements were repeated in obese patients 6 months after surgery.

Eligibility criteria:
inclusion criteria: * age ranged from 16-65 years old * bmi over 37.5kg/m2, or bmi over 32.5kg/m2 with diabetes which meets the recommended cut-off bariatric surgery of the guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in china. exclusion criteria: * secondary causes of obesity such as hypothalamic obesity, cushing syndrome, hypophysis dysfunction, etc * pregnancy or location * contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesion, etc * severe heart, liver, and kidney dysfunction * organic and systemic diseases intolerant of surgery.

Keywords: obesity functional neuroimaging brain artificial intelligence
creating a tissue bank of knee capsules

Conditions: Osteoarthritis; Knee Joint Contractures

Summary: a contracture is a pathological condition limiting range and function of joints. contractures of large and small joints alike will affect one's ability to independently perform daily activities such as eating, dressing or walking. current treatments for contractures include physical stretching, the use of assistive devices or, rarely, surgery. despite prolonged treatments, patients with contractures rarely regain complete mobility. progress in preventing and treating contractures will be possible only through an understanding of the biological and molecular processes involved. our group has established and validated an animal model to study the histological events and the molecular mechanisms involved in joint contractures. we have provided evidence for capsule stiffness, characterized cartilage degeneration, and identified four genes whose expression is altered in the cartilage of a knee joint with contracture. the work we propose in the current study aims at finding genes and pathways in the joint capsule associated with knee joint contractures. the results will identify new avenues for treating the large number of patients suffering from contractures.

we propose to constitute a bank of capsule samples from people with osteoarthritis undergoing primary total knee arthroplasty. it is expected that about 1.3% of people will develop a contracture post arthroplasty. a second sample will be taken from those that require surgery for release of contracture or revision. we will study histological characteristics and compare gene expression between the primary sample and the contracture sample in the same patient. in order to determine whether intrinsic genetic factors influence the develpment of joint contractures in the osteoarthritis population, all specimens will be analyzed for differential gene expression between patients with and without knee contractures post arthroplasty. the remaining capsule tissue not used for this study will be banked and made available to other researchers.

Eligibility criteria:
inclusion criteria: * osteoarthritis, booked for a total knee arthroplasty exclusion criteria: * transmissible disease (e.g., hiv infection, hepatitis b or c) * suspected neoplasia * suspected infection (which can cause arthrofibrosis) * hypertrophic scarring

Keywords: contractures total knee arthroplasty tissue bank osteoarthritis gene expressions
maveropepimut-s (mvp-s) and low-dose cpa in patients with platinum-resistant ovarian cancer

Conditions: Platinum-resistant Epithelial Ovarian Cancer

Summary: phase 2, single arm, study to assess the efficacy and safety of maveropepimut-s (mvp-s) and low-dose cyclophosphamide (cpa) in subjects with recurrent, platinum resistant ovarian cancer.

a simon two-stage statistical design to assess mvp-s in combination with low dose cpa in platinum-resistant epithelial ovarian cancer patients who have received no greater than 4 previous lines of anti-cancer therapy. mvp-s, previously called dpx-survivac, was recently evaluated in a small phase 2 single arm study of ovarian cancer patients known as decide1 (nct02785250).

Eligibility criteria:
key inclusion criteria: * stage iii or iv epithelial ovarian, fallopian tube, or primary peritoneal cancer, histologically diagnosed high-grade serous * platinum-resistant disease (relapsing within 3-6 months after completion of initial platinum-based treatment). patients progressing at any time on or after ≥ 2nd platinum-based therapy are eligible. * received ≤ 4 prior lines of anti-cancer therapy for ovarian cancer, including at least one platinum-based therapy * evidence of progressive disease * measurable disease (recist v1.1) with at least one non-target lesion accessible by image-guided biopsy. no single lesion may be larger than 4 cm in diameter. * completed pre-treatment tumor biopsy and willing to undergo on-treatment tumor biopsy * ecog 0-1 * live expectancy ≥ 6 months * meet protocol-specified laboratory requirements key exclusion criteria: * concurrent chemotherapy drugs, anti-cancer therapy or anti-neoplastic hormonal therapy, or radiotherapy * prior receipt of survivin-based vaccines/therapy, immune checkpoint inhibitors, ido inhibitor, or cell-based therapy * non-epithelial tumor origin of the ovary, fallopian tube, or peritoneum * clinical ascites * concurrent second malignancy other than basal or squamous cell skin cancer, cervical carcinoma in situ, or stage i or ii caner in complete remission * gi condition that might limit absorption of oral agents * recent history of thyroiditis * history of autoimmune disease requiring treatment within the last two years (except paraneoplastic syndrome, vitiligo, or diabetes) * history of bowel obstruction related to the disease * presence of a serious acute infection or chronic infection * uncontrolled concurrent illness or history of significant cardiac or pulmonary disfunction * myocardial infarction or cerebrovascular event within past 6 months * known central nervous system (cns) or leptomeningeal metastasis (brain metastases) * clinically significant illness or major surgery within past 28 days or anticipated need for major surgery during study treatment * ongoing treatment with steroid therapy or other immunosuppressive * receipt of live attenuated vaccines * edema or lymphedema in the lower limbs \> grade 2 * acute or chronic skin and/or microvascular disorders

Keywords: t cell education dpx-survivac immunotherapy platinum-resistant (proc) high grade serous (hgsoc)